4006 – ASCA IgA
Intended Purpose
The ASCA IgA is a quantitative immunoassay for the determination of IgA antibodies against Saccharomyces cerevisiae in human serum. The ASCA IgA is intended as an aid in the diagnosis of Crohn´s disease in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.
Diagnostic Relevance
Non-specific inflammatory bowel disease including Crohn’s disease (CD) (Enteritis regionalis) and ulcerative colitis (UC) are characterised by chronic-remitting inflammatory processes of the intestine. Immunologic, genetic, infectious and environmental factors have been identified as the risk factors of developing one of these diseases. An important serological marker for the differential diagnosis of Crohn’s disease is the determination of IgA and IgG antibodies to Saccharomyces cerevisiae, which are highly prevalent (70 %) in patients with CD and atypical antineutrophile cytoplasmatic antigens (aANCA). Thus, ASCA, in combination with the detection of autoantibodies to atypical anti-neutrophil cytoplasmic antigens (aANCA), are a valid parameter for the differentiation of Crohn’s disease and ulcerative colitis.
Product Specifications
| Title | ASCA IgA |
| Product code | 4006 |
| Indication | Crohn’s disease |
| Description | Enzyme immunoassay for the quantitative determination of IgA antibodies against Saccharomyces cerevisiae in human serum |
| Format | Microtiter plate coated with mannan from Saccharomyces cerevisiae |
| Total incubation time | 105 min. |
| Sample volume | 10 µL serum |
| No. of determinations | 96 (89 x 1) + 5 x Calibrators + 2 x Controls |
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Current version of the instructions for use. The respective valid version for processing the test can be found in the product packaging.